National clinical trials of a controversial treatment for multiple sclerosis not sanctioned in Canada could begin next year, with the federal government joining a small group of provinces and territories studying the experimental procedure.
Federal Health Minister Leona Aglukkaq announced on Friday that the government is seeking research proposals to study the so-called liberation therapy and hopes to choose a team by next March.
Ms. Aglukkaq said in Halifax at the conclusion of Canada’s health ministers’ two-day annual meeting that it is too early to say how many patients will participate in the trial or how much it will cost. But provincial government sources said Ottawa is budgeting $3-million to $5-million for the project, which will involve about 80 to 90 patients. The sources said the trial should be up and running in about a year.
The announcement marks a change of heart for the federal government. A year ago, Ms. Aglukkaq accepted the position of the Canadian Institutes of Health Research (CIHR) that it was too soon to conduct clinical trials on the liberation therapy procedure pioneered by Italian doctor Paolo Zamboni. The Multiple Sclerosis Society of Canada also supported that stance.
But last June, the door began opening to clinical trials in this country when Health Canada agreed with a recommendation from the CIHR that there was enough scientific evidence to merit a small research study. The CIHR and the MS Society are collaborating in Ottawa’s request for proposals.
“I think it’s good news,” Alberta Health Minister Fred Horne said in an interview. “We’ll have to see who applies for the funding, but I think this is a big step forward in terms of getting clinical trials going in Canada.”
Saskatchewan Premier Brad Wall called attention to the therapy in June, 2010, when he announced that his province planned to start clinical trials, even though Ms. Aglukkaq and the health-research community were insisting it was too risky. The province has the highest rate of MS in the country.
“He put this on the national stage,” Saskatchewan Health Minister Don McMorris said in an interview. “Within a year, it has moved forward, as far as governments are concerned, quite quickly [but]as far as patients are concerned, never quickly enough.”
MS is a debilitating disease that can affect vision, memory, hearing, balance and mobility. The benefits of liberation treatment – an experimental method of opening veins in the neck and spinal cord to combat the symptoms of the nerve-wasting MS disease – have been widely disputed by health experts.
Hundreds of Canadians have sought out the treatment overseas, including an Ontario man named Mahir Mostic, who died last year after undergoing an angioplasty in a Costa Rican clinic.
Despite the Saskatchewan government’s efforts, it was not able to conduct clinical trials in the province, even though both Manitoba and Yukon wanted to participate. Saskatchewan received only one proposal from researchers and it did not meet criteria set by an expert panel.
The province looked farther afield and announced in September that it is partnering with U.S. researchers. Saskatchewan plans to send 80 patients to Albany, N.Y., for clinical trials involving a total of 160 patients. The province is setting aside $2-million to cover all expenses, including hotels, travel and food.
Mr. McMorris said his province will also participate in any future trials funded by the federal government.
With a report from Josh Wingrove in Edmonton